Trial reportAlimentary pharmacology & therapeutics2012
Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS.
Trial report in Alimentary pharmacology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.
- Ramosetron for the treatment of irritable bowel syndrome with diarrhea: a systematic review and meta-analysis of randomized controlled trials.BMC gastroenterology · 2018Pooled it
- Pooled it
- Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome.Alimentary pharmacology & therapeutics · 2017Trial
- A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea.Gut · 2014Trial
- The Effect of Ondansetron on Improvement of Symptoms in Patients with Irritable Bowel Syndrome with Diarrhea Domination: A Randomized Controlled Trial.Middle East journal of digestive diseases · 2024Article
- Development and Validation of a High-Performance Liquid Chromatography Method to Quantify Marker Compounds inMolecules (Basel, Switzerland) · 2024Article
- Evidence-based clinical practice guidelines for irritable bowel syndrome 2020.Journal of gastroenterology · 2021Article
- Potential neuro-immune therapeutic targets in irritable bowel syndrome.Therapeutic advances in gastroenterology · 2020Review
- The Incidence of Sexual Dysfunction in Patients With Irritable Bowel Syndrome.Sexual medicine · 2019Review
- An Association of Serotonin with Pain Disorders and Its Modulation by Estrogens.International journal of molecular sciences · 2019Review
- Update on Pharmacotherapy for Irritable Bowel Syndrome.Current gastroenterology reports · 2019Review
- The Impact of Revascularisation on Quality of Life in Chronic Mesenteric Ischemia.Canadian journal of gastroenterology & hepatology · 2019Article
- 5-HTAmerican journal of physiology. Gastrointestinal and liver physiology · 2019Article
- Review article: an analysis of safety profiles of treatments for diarrhoea-predominant irritable bowel syndrome.Alimentary pharmacology & therapeutics · 2018Review
- Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint.Therapeutic advances in gastroenterology · 2018Article
- Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial.Therapeutic advances in gastroenterology · 2017Article
- Current and emergent pharmacologic treatments for irritable bowel syndrome with diarrhea: evidence-based treatment in practice.Therapeutic advances in gastroenterology · 2017Review
- Identification of a Novel Allosteric Inhibitory Site on Tryptophan Hydroxylase 1 Enabling Unprecedented Selectivity Over all Related Hydroxylases.Frontiers in pharmacology · 2017Article
- RGS proteins as targets in the treatment of intestinal inflammation and visceral pain: New insights and future perspectives.BioEssays : news and reviews in molecular, cellular and developmental biology · 2016Review
- Irritable bowel syndrome: new insights into symptom mechanisms and advances in treatment.F1000Research · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with irritable bowel syndrome with diarrhoea (IBS-D) experience restriction in daily activities and decreased health-related quality of life (QOL).
aimTo investigate effects of alosetron on patient-reported health-related QOL, satisfaction and productivity in women with severe IBS-D.
methodsA total of 705 women (severe IBS-D, Rome II criteria) randomised to alosetron 0.5 mg QD, 1 mg QD, 1 mg BID, or placebo for 12 weeks were studied. IBSQOL, treatment satisfaction, daily activities, and lost workplace productivity (LWP) were evaluated at randomisation and Week 12.
resultsOne or more doses of alosetron significantly improved all IBSQOL domains except for sexual function from baseline vs. placebo. The magnitude of IBSQOL changes was consistent with a clinically meaningful effect. Alosetron 0.5 mg QD and 1 mg BID significantly reduced IBS interference with social/leisure activities and LWP from baseline vs. placebo [social/leisure (mean ±S.E.) days lost: -6.7 ± 0.8, -7.0 ± 0.9, P < 0.01; LWP (mean ± S.E.) h lost: -11.0 ± 3.3, -21.1 ± 4.1, P < 0.05 respectively]. Significantly more patients treated with alosetron reported satisfaction vs. placebo. Improvements in IBSQOL, LWP, and treatment satisfaction significantly correlated with global improvement of IBS symptoms. The incidence of adverse events with alosetron was low with constipation being the most commonly reported event. A single case of ischaemic colitis occurred, in a patient receiving alosetron 0.5 mg QD.
conclusionsIn women with severe IBS-D, alosetron treatment, including 0.5 mg QD, resulted in statistically significant and clinically relevant improvements in health-related QOL, restriction of daily activities and treatment satisfaction over placebo. IBS symptom improvement corresponded with positive changes in IBSQOL, LWP and treatment satisfaction.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.